For some medical devices, the characteristics of the device are between ordinary medical devices (MD), in vitro diagnostic devices (IVD), and implantable medical devices (AIMD). It is not easy to classify them and it is easy to cause confusion. In December 2017, the European Commission released the latest version of Manual onBorderline and Classification in the Community Regulatory Framework for MedicalDevices. The main updates are as follows:
- Reduce Alcohol Absorption Products
This product is a suspension taken before drinking to reduce intestinal alcohol absorption and reduce blood alcohol content. Such products are not considered medical devices.
- Radiation Protection Products
Although radiation protection products can reduce the risk of individuals suffering from radiation, radiation itself is not a disease, so these products are not considered medical devices.
- Prevention Of Urinary Tract Infection With Mannose
Mannitol prevents urinary tract infections through pharmacological effects rather than physical barriers, so it should be drugs and not considered medical devices.
- 8-methoxypsoralen (8-MOP) Solution For Photochemotherapy
8-MOP is not an accessory for plasmapheresis devices or ultraviolet irradiation devices. It functions through pharmacological, immunological, and metabolic mechanisms and therefore does not meet the definition of medical devices and is not considered a medical device.
- Minghao Hemostatic Pen
These products are not considered as cosmetic products because of direct contact with the damaged skin; they mainly act by depositing proteins on the surface of the skin, compressing tissues, and controlling blood flow, and are not pharmacological, immunological, or metabolic. Therefore, they are considered to belong to Class IIa medical devices.
- Microplate Washer
This washing machine is not used to directly detect specimens. It is an ordinary laboratory equipment and is not considered as an in vitro diagnostic instrument.
- Breast Tissue Expanders
The use time of the dilator is at least 30 days. It is a breast implant product. According to Directive 2003/12/EC, it is considered to be a Class III medical device.
- Dura Protector Used With Craniotomy
Such products should be in contact with the inner surface of the skull and directly contact the dura and should be Class III medical devices.
- Heart Bypass Catheter
In cardiopulmonary bypass surgery, extracorporeal blood circulation is assisted by a cardiopulmonary bypass device. Aortic catheters and intravenous catheters are an important part of the extracorporeal circulation and are in direct contact with the central circulatory system and are considered to belong to Class III medical devices.
- Liquid Nitrogen For Cryogenic Storage Of Human Cells Or Tissues For Medical Use
When liquid nitrogen is used to cryopreserve human tissues or cells for retransplantation or reapplied to the human body, it is considered to belong to Class IIa medical devices.
- Mobile App To Manage Skin Photographs
This kind of app is only used for taking and storing pictures of skin defects, does not operate on stored images, and does not belong to the software embedded in medical devices. This type of application software does not belong to independent medical device software.
- Evaluate Skin Defects In Mobile Application Software
These apps are used to capture and store images of skin defects and follow-up comparisons, and perform detailed assessments after scanning the skin as per image processing algorithms. In addition, the probability that skin moles are melanomas will also be evaluated to support the early diagnosis of skin cancer, which is considered to belong to Class I medical devices.
Source: Food and Drugs Audit Center of the State Food and Drug Administration
